Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
USNovel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
Recalling Firm: Novel Laboratories, of Somerset, N.J.
Grund für den Rückruf / Gefahr
TranslatedThe packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children.
Produktbeschreibung & Identifikation
TranslatedThis recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets from Novel Laboratories. The prescription medication is a sleep drug. The packaging for the 1.75 mg tablets has lot number M16140A, 1.75 mg and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets has lot number M16144A, 3.5mg and national drug code (NDC) 43386-761-30. The Zolpidem Tartrate is packaged as a single tablet in a peel-and-push blister pack inside an outer open-ended pouch with 30 pouches per box. The lot number and an expiration date of 02/2018 are printed on the bottom left of the pouches. The NDC is printed on the top left corner of the boxes. "Gavis" is printed in blue on the center of the white boxes and pouches.
Betroffene Produkte
TranslatedZolpidem Tartrate Sublingual tablets
Additional Source Details
| Field | Value |
|---|---|
| U R L | https://www.cpsc.gov/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs |
| Title | Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning |
| Images › 1 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232a.jpg |
| Images › 1 › Caption | Novel Laboratories sleep tablets 1.75 mg box (front) |
| Images › 2 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232b.jpg |
| Images › 2 › Caption | Novel Laboratories sleep tablets 1.75 mg envelope (front) |
| Images › 3 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232c.jpg |
| Images › 3 › Caption | Novel Laboratories sleep tablets 1.75 mg envelope (back) |
| Images › 4 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232d.jpg |
| Images › 4 › Caption | Novel Laboratories sleep tablets 3.5 mg box (front) |
| Images › 5 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232e.jpg |
| Images › 5 › Caption | Novel Laboratories sleep tablets 3.5 mg envelope (front) |
| Images › 6 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232f.jpg |
| Images › 6 › Caption | Novel Laboratories sleep tablets 3.5 mg envelope (back) |
| Hazards › Name | The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children. |
| Injuries › Name | None reported |
| Products › Name | Zolpidem Tartrate Sublingual tablets |
| Products › Type | Tablet or Capsule Drugs |
| Products › Category I D | 68198 |
| Products › Number Of Units | About 5,700 boxes of 30 blister packs |
| Recall I D | 7814 |
| Remedies › Name | Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund. |
| Retailers › Name | Clinics and pharmacies nationwide, including CVS, Costco, Walgreens, Kroger, and Wegmans from March 2016 through May 2016 for about $800 per box of 30 tablets. |
| Recall Date | 2016-07-27T00:00:00 |
| Description | This recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets from Novel Laboratories. The prescription medication is a sleep drug. The packaging for the 1.75 mg tablets has lot number M16140A, 1.75 mg and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets has lot number M16144A, 3.5mg and national drug code (NDC) 43386-761-30. The Zolpidem Tartrate is packaged as a single tablet in a peel-and-push blister pack inside an outer open-ended pouch with 30 pouches per box. The lot number and an expiration date of 02/2018 are printed on the bottom left of the pouches. The NDC is printed on the top left corner of the boxes. "Gavis" is printed in blue on the center of the white boxes and pouches. |
| Product U P Cs › 1 › U P C | 343386761012 |
| Product U P Cs › 2 › U P C | 343386762019 |
| Distributors › Name | Gavis Pharmaceuticals, of Somerset, N.J. |
| Recall Number | 16232 |
| Manufacturers › Name | Novel Laboratories, of Somerset, N.J. |
| Remedy Options › Option | Refund |
| Consumer Contact | Novel Laboratories toll-free at (866) 403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.novellabs.net and click on "Important Zolpidem Information" for more information. |
| Last Publish Date | 2016-07-27T00:00:00 |
| Manufacturer Countries › Country | United States |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (CPSC).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement...?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (CPSC). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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- Rückrufendes UnternehmenNovel Laboratories, of Somerset, N.J.
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